Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00185367
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Cycle Control Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 798}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-14', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding pattern', 'timeFrame': '7 treatment cycles each consisting of 28 days'}, {'measure': 'Number of unintended pregnancies', 'timeFrame': '7 treatment cycles each consisting of 28 days and follow-up period of 14 days'}], 'secondaryOutcomes': [{'measure': 'Adverse event collection', 'timeFrame': '7 treatment cycles each consisting of 28 days and follow-up period of 14 days'}]}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '19835717', 'type': 'DERIVED', 'citation': 'Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female volunteers aged between 18 and 50 years requiring contraception\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Any conditions that might interfere with the outcome as well as all contraindications for OC use'}, 'identificationModule': {'nctId': 'NCT00185367', 'briefTitle': 'Comparative Cycle Control Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.', 'orgStudyIdInfo': {'id': '90883'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2004-001613-34'}, {'id': '304004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: SH D 593 B (Miranova)']}], 'interventions': [{'name': 'EV/DNG (Qlaira, BAY86-5027, SH T00658K)', 'type': 'DRUG', 'description': '7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo', 'armGroupLabels': ['Arm 1']}, {'name': 'SH D 593 B (Miranova)', 'type': 'DRUG', 'description': '7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74245', 'city': 'Fulnek', 'country': 'Czechia', 'facility': 'Soukroma gynekologicka ambulance', 'geoPoint': {'lat': 49.71238, 'lon': 17.90319}}, {'zip': '30708', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Soukroma gynekologicka ambulance', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '109 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Provozorna Gynekologicka ordinace Dr. Tesar', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '13000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Femina Sana s.r.o', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '70400', 'city': 'Zábřeh nad Odrou', 'country': 'Czechia', 'facility': 'Soukroma gynekologicka ambulance', 'geoPoint': {'lat': 49.79703, 'lon': 18.23309}}, {'zip': '83170', 'city': 'Brignoles', 'country': 'France', 'facility': 'Dr. Jocelyne Nataf-Maurin', 'geoPoint': {'lat': 43.4058, 'lon': 6.06172}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Dr. Marie-Helene Malbranche-Aupecle', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '14601', 'city': 'Honfleur', 'country': 'France', 'facility': 'Centre Hospitalier de l Estuaire', 'geoPoint': {'lat': 49.41985, 'lon': 0.23294}}, {'zip': '29600', 'city': 'Morlaix', 'country': 'France', 'facility': 'Dr. Annette Mercier', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'zip': '31600', 'city': 'Muret', 'country': 'France', 'facility': 'Clinique d Occitanie', 'geoPoint': {'lat': 43.45998, 'lon': 1.32541}}, {'zip': '58000', 'city': 'Nevers', 'country': 'France', 'facility': 'Centre Medical du Val de Loire', 'geoPoint': {'lat': 46.98956, 'lon': 3.159}}, {'zip': '75007', 'city': 'Paris', 'country': 'France', 'facility': 'Dr. Anne-Isabelle Richet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '21800', 'city': 'Quetigny', 'country': 'France', 'facility': 'Cabinet medical', 'geoPoint': {'lat': 47.31667, 'lon': 5.11667}}, {'zip': '69170', 'city': 'Tarare', 'country': 'France', 'facility': 'Dr. Gwendoline Servan', 'geoPoint': {'lat': 45.89614, 'lon': 4.433}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Dr. Aliette Siboni-Frisch', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '85579', 'city': 'Neubiberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Frauenarztpraxis Dr. Buchberger', 'geoPoint': {'lat': 48.0771, 'lon': 11.65812}}, {'zip': '90491', 'city': 'Nuremberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Praxis Hr. Dr. R. Kuett', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '36037', 'city': 'Fulda', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Praxis Dr. Larbig', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'zip': '30159', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Praxis Fr. Dr. J. Schmidt-Pich', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '04720', 'city': 'Döbeln', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Praxis Fr. Dr. A. Münzberger', 'geoPoint': {'lat': 51.1221, 'lon': 13.11027}}, {'zip': '01169', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Praxis Fr. Dr. K. Kopprasch', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01187', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Praxis Fr. R. Hellmich', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '04207', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Frauenarztpraxis Dr. Bernd Pittner', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04299', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Praxis Fr. Dr. C. Burgkhardt', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '38889', 'city': 'Blankenburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Frauenarztpraxis Dr. Wetzel', 'geoPoint': {'lat': 51.79025, 'lon': 10.95509}}, {'zip': '39288', 'city': 'Burg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Frauenarztpraxis Dipl. med. Michael Stellmacher', 'geoPoint': {'lat': 51.42285, 'lon': 11.99333}}, {'zip': '39104', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Praxis Fr. Dr. A. Braune', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '39126', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Praxis Hr. Prof. Dr. H.-J. Ahrendt', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '10247', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Frauenarztpraxis Hr. Dr. H. Lindecke', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12587', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Praxis Fr. Dr. B. Heuberger', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13086', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Praxis Hr. Dr. Karl-Heinz Belling', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13187', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Frauenarztpraxis Hr. Dr. B. Hamann', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '07545', 'city': 'Gera', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Praxis Hr. R. Wähnert', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'zip': '07768', 'city': 'Kahla', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Praxis Fr. Dr. A.Mönch-Hering', 'geoPoint': {'lat': 50.80651, 'lon': 11.58516}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Bayer Healthcare AG'}}}}